A Study to Investigate the Pharmacodynamic Effects of CT327 on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers

This study has been completed.
Sponsor:
Collaborator:
Aalborg Universitetshospital
Information provided by:
Creabilis SA
ClinicalTrials.gov Identifier:
NCT01243307
First received: November 17, 2010
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

The primary objective of this study is to compare the effect of CT327 to placebo against experimental induced superficial, deep and hyperalgesic pain.

The secondary objectives are to elucidate the mechanisms of CT327 using experimental pain models.


Condition Intervention Phase
Neuropathic Pain
Drug: CT327 (or placebo) followed by placebo (or CT327)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Phase I, Single-centre, Multiple-dose, Placebo-controlled Crossover Study to Investigate the Pharmacodynamic Effects of CT327 (0.1% Topical Cream) on Intra-dermal Nerve Growth Factor (NGF) and Evoked Pain Responses, in Healthy Male Volunteers

Resource links provided by NLM:


Further study details as provided by Creabilis SA:

Primary Outcome Measures:
  • An alteration in the peripheral sensitisation after treatment with CT327 [ Time Frame: 2 treatment/testing periods each lasting 4 days and separated by at least 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change in pain determined with the visual analogue scale (VAS) and the change in areas assessed with von Frey filaments and standardized brush. [ Time Frame: 2 treatment/testing periods each lasting 4 days and separated by at least 10 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2011
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CT327 treatment period 1
Subjects in Group 1 will receive CT327 during treatment/testing period 1 and placebo during treatment/testing period 2
Drug: CT327 (or placebo) followed by placebo (or CT327)

During treatment/testing period 1, subjects will apply 0.25 g CT327 (or placebo) to 4 test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications.

During treatment/testing period 2, subjects will apply 0.25 g placebo (or CT327) to 4 different test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications.

Experimental: CT327 treatment period 2
Subjects in Group 2 will receive placebo during treatment/testing period 1 and CT327 during treatment/testing period 2
Drug: CT327 (or placebo) followed by placebo (or CT327)

During treatment/testing period 1, subjects will apply 0.25 g CT327 (or placebo) to 4 test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications.

During treatment/testing period 2, subjects will apply 0.25 g placebo (or CT327) to 4 different test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications.


  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must be able to understand the contents of the study, comply with the study and willing to sign informed consent
  • Subjects must be free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests
  • All male subjects must take adequate contraceptive precautions during the course of the study and for 30 days after their participation in the study has ended

Exclusion Criteria:

  • Participation in other clinical studies within 3 months before screening
  • Scheduled for surgery, medical treatment or any hospital admission that would fall within the study
  • Use of strong painkillers
  • Use of any analgesic within 24 hours before start of study
  • Use of a regular course of prescribed medication and/or herbal medicine
  • The presence of lesions, significant scars, cuts, wounds, dermal abnormalities, tattoos or naevi in the test areas
  • A past history of contact dermatitis, psoriasis or keloid
  • Any clinically significant ECG abnormality at screening
  • A history of drug or other allergy that contraindicates his participation.
  • Regular or average consumption of more than 21 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 125 mL of wine or 20 mL of spirits).
  • Smokes more than five cigarettes (on average) per day, or had been a smoker of more than 5 cigarettes (on average) per day within the 3 months prior to screening.
  • A known history of drug or alcohol abuse.
  • As a result of the medical screening process, the PI or medical delegate considers the subject unfit for the study.
  • Use of any prescription medication within 2 weeks or 5 half-lives (whichever is longer) of dosing.
  • Use of non-prescription medication (e.g. aspirin, vitamins and herbal and dietary supplements) within 7 days prior to dosing, or 14 days if the medication contained grapefruit/ grapefruit juice or St John's Wort.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243307

Locations
Denmark
Department of Gastroenterology Aalborg Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
Creabilis SA
Aalborg Universitetshospital
  More Information

No publications provided

Responsible Party: Creabilis Therapeutics
ClinicalTrials.gov Identifier: NCT01243307     History of Changes
Other Study ID Numbers: CT327-1002
Study First Received: November 17, 2010
Last Updated: June 6, 2011
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Neuralgia
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2014